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US FDA publishes 200 rejection letters in transparency push
The U.S. Food and Drug Administration on Thursday published more than 200 of its so-called complete response letters to ...
Enrollment Initiated in Jaguar Health Study of its FDA Conditionally Approved Canalevia-CA1 Prescription Drug for Dogs
In discussions with multiple potential animal health company partners to collaborate to bring Canalevia®, conditionally ...
Moderna’s Covid Shot Fully Approved by FDA for Use in Kids
US regulators approved Moderna Inc.’s Covid vaccine for children, but for a narrower group than before, continuing Robert F.
FDA Issues Highest Risk Warning for Nationwide Chocolate Recall
Weaver Nut Company, Inc. announced a recall for specific lots of its semi-sweet chocolate nonpareils on June 17 due to the undeclared presence of milk.
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Pharmalittle: We’re reading about Regeneron’s patent maneuvers, FDA rejection letters, and lots more
A court battle between Regeneron and Amgen is testing the legal limits of how far drugmakers can go in using patents to ...
FDA Layoffs Could Compromise Safety of Medications Made at Foreign Factories, Inspectors Say
Beyond staff cuts, the departures of some longtime investigators in recent months have left less experienced people tasked ...
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Vessel Sealer Curved receives FDA clearance
Vessel Sealer Curved is a fully wristed, advanced bipolar electrosurgical instrument designed to seal, cut, grasp, and ...
Medical groups urge Kennedy, FDA to reexamine broad approval of abortion drugs
Pro-life medical groups are urging Health and Human Services Secretary Robert Kennedy Jr. to reexamine the FDA’s broad ...
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Inside the staff exodus and tanking morale that threaten Makary’s FDA
WASHINGTON — The steady erosion of experienced staff at the Food and Drug Administration is slowly compromising the agency’s ...
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FDA Issues Early Alert for Medtronic pH Monitoring Capsules
Used for diagnosing gastroesophageal reflux, the devices may not attach or detach correctly, potentially causing serious ...
PharmExec39m
FDA Grants Orphan Drug Designation to Adcentrx Therapeutics’ ADRX-0405 STEAP1 ADC
ADRX-0405 is uniquely being tested during its 1a/b clinical trials. ADRX-0405 is labeled as a STEAP1 ADC (primarily ...
Nationwide Gummies Recall Update as FDA Issues Highest Risk Warning
Vita Warehouse Corp. recalled more than 40,000 bottles of Vitamin B12 supplements for possible undeclared presence of peanut.